A multimodal manual therapy, exercise, and psychological intervention for painful diabetic neuropathy: the NeuOst feasibility randomised controlled trial.
Introduction: People with painful diabetic neuropathy lack effective and tolerable treatments. Physical and psychological interventions may help but require further study and combination to maximise effects. Objectives: This single-site, 3-arm, parallel, randomised feasibility trial tested whether a multimodal intervention combining manual therapy, exercise, and psychologically informed conversations ("NeuOst") was feasible, and a full-scale trial possible. Methods: Adults with painful diabetic neuropathy were randomised 1:1:1 to either (1) 5 individual sessions of NeuOst, (2) 5 sessions of a high-similarity control intervention with the same osteopaths, or (3) usual care. Allocation was computer-generated, and blinding was intended for assessors, research and administrative staff, and participants receiving NeuOst or the high-similarity control intervention. Feasibility and acceptability were assessed using predefined criteria. Exploratory clinical outcomes included pain, disability, and quality of life, collected up to 16 weeks post-randomisation. Results: Thirty-six participants were randomised; targets were met for eligibility (64%), consent (88%), retention (89%), blinding, fidelity, data completeness, and acceptability. Mean NeuOst session attendance was 82%, and satisfaction was high (mean 4.8/5). No serious adverse reactions occurred. Minor adverse responses were reported by 25% of NeuOst and 42% of control intervention participants. Recruitment rates indicated that modified procedures would be needed for a larger trial. Clinical outcomes were uncertain compared with control and promising compared with usual care. Conclusion: The NeuOst intervention was safe, acceptable, and feasible. The trial design proved largely workable, with areas for refinement identified. Findings support progression to an effectiveness trial.
Authors
- Esther M Williamson (ORCID: https://orcid.org/0000-0003-0638-0406)
- Whitney Scott (ORCID: https://orcid.org/0000-0002-2529-9083)
- Nuno Koch Esteves (ORCID: https://orcid.org/0000-0002-0580-7642)
- Sam Tan
- Jan David Wandrey (ORCID: https://orcid.org/0000-0002-4470-6393)
- Philip Bright (ORCID: https://orcid.org/0000-0002-5339-8281)
- Elizabeth Pigott
- David Hohenschurz‐Schmidt (ORCID: https://orcid.org/0000-0002-1964-6069)
- Jerry Draper‐Rodi (ORCID: https://orcid.org/0000-0002-1900-6141)
- Matthew C. Evans (ORCID: https://orcid.org/0000-0003-1016-3228)
- Jan Vollert (ORCID: https://orcid.org/0000-0003-0733-5201)
- Andrew S.C. Rice (ORCID: https://orcid.org/0000-0001-9533-5636)
- Sasha Smith (ORCID: https://orcid.org/0000-0001-9843-5368)
- David W. Evans (ORCID: https://orcid.org/0000-0002-9073-5558)
- Esther Miriam Pogatzki-Zahn (ORCID: https://orcid.org/0000-0003-0981-3940)
- Annina B Schmid
- Suzie Cro
- Siobhán Stynes
- Steven Vogel
- Harriet Kemp
Institutions
- St Thomas' Hospital (GB)
- Imperial College Healthcare NHS Trust (GB)
- King's College London (GB)
- Guy's and St Thomas' NHS Foundation Trust (GB)
- Health Sciences University (GB)
- University of Exeter (GB)
- Charing Cross Hospital (GB)
- University College of Osteopathy (GB)
- John Radcliffe Hospital (GB)
- Humboldt-Universität zu Berlin (DE)
- University of Oxford (GB)
- University Hospital Münster (DE)
- Midlands Partnership NHS Foundation Trust (GB)
- Berlin Institute of Health at Charité - Universitätsmedizin Berlin (DE)
- University of Southampton (GB)
- Imperial College London (GB)
- Keele University (GB)
- Charité - Universitätsmedizin Berlin (DE)
- University of Birmingham (GB)
Publication Details
- Journal
- PubMed
- Published
- 2026-10-01
- DOI
- https://doi.org/10.1097/pr9.0000000000001498
- Primary Topic
- Pain Mechanisms and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- AstraZeneca
- Stowers Institute for Medical Research
- Royal British Legion
- South London and Maudsley NHS Foundation Trust
- Wellcome Trust
- Hospital for Special Surgery
- European Federation of Pharmaceutical Industries and Associations
- UK Research and Innovation
- National Institute for Health and Care Research
- Department of Health and Social Care
- Imperial College London
- King's College London
- Chelsea and Westminster Hospital NHS Foundation Trust
- European Commission
- Deutsche Forschungsgemeinschaft
- Bundesministerium für Bildung und Forschung
- United Arab Emirates University
- European Society of Anaesthesiology
- Versus Arthritis
- Gemeinsame Bundesausschuss
- Berlin Institute of Health
- Medical Research Council
- Biotechnology and Biological Sciences Research Council
- Economic and Social Research Council